Medinumb Cream
FDA Label NDC 71383-024

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Valekista Limited for the product Medinumb (NDC 71383-024). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, otc - do not use, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine 4%

Purpose

Topical Analgesic

Use

For the temporary relief of pain

Warnings

For external use only

Avoid contact with eyes

Not for prolonged use

Otc - Do Not Use

Do not use in large quantities, particularly over raw surfaces or blistered areas

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms persist for more than 7 days or clears up and occurs again within a few days
  • rash or irritation develops, persists or increases

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away: 800-222-1222

Directions

Adults and children 2 years and older

  • clean the affected area
  • apply to affected area not more than 3 to 4 times daily
  • remove residue if desired
  • Children under 2 years old: Consult a doctor

Other Information

  • Store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

Inactive Ingredients

Aloe barbadensis leaf juice, arginine, benzophenone-4, cetyl alcohol, dimethyl sulfoxide, melaleuca alternifolia (tea tree) leaf oil, phenoxyethanol; (and) caprylyl glycol (and) potassium sorbate (and) water (and) hexylene glycol, purified water, simmondsia chinensis (jojoba) seed oil, sodium polyacrylate, stearic acid

Questions Or Comments?

877-557-1135 or www.medinumb.com

Other

Distributed by: Valekista Limited, Pacific Plaza, Western District, HK

Principal Display Panel - 56 G Tube Box

MEDINUMB™

4% Lidocaine Cream
Pain Relieving Topical Anesthetic
Medicated Cream to Numb The Skin

MAXIMUM STRENGTH
NET WT. 2oz.(56g)

Principal Display Panel (56 g Tube Box)

Principal Display Panel (56 g Tube Box)

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